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临床试验/NCT03544320
NCT03544320已完成不适用

Prediction Using a Randomized Evaluation of Data Collection Integrated Through Connected Technologies for Diabetes Management

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2018年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Change in hemoglobin A1c

研究概览

简要总结

In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

详细描述

Patients with suboptimal glycemic control could be better managed if these higher risk patients could be identified and effective interventions were then targeted towards them. However, most practice settings perform infrequent laboratory testing every 3 to 6 months, if not at longer intervals. Current models to predict change in glycemic control perform poorly and do not take into account the behaviors that occur between these intervals. In this study, we will compare different methods to use data on daily health behaviors collected by wearable devices to enhance risk prediction models. Adults with pre-diabetes will complete a series of surveys and baseline assessments and then will be randomly assigned to use a waist-worn or wrist-worn wearable device for 6 months. Measures of HbA1c and LDL will be obtained at baseline and at 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The participants will be aware of the two different study arms and the wearable devices used in both. The study investigator will not have not have knowledge of the participants assigned to each arm.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be 18 years or older
  • Be able to provide informed consent
  • Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
  • Baseline hemoglobin A1c of 5.7 to 6.4

排除标准

  • Participants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study

研究组 & 干预措施

Activity Monitoring-Wrist worn wearable

Active Comparator

Participants in the activity monitoring-wrist worn wearable group will be randomly assigned to track their activity using a Fitbit Charge 2 for 6 months.

干预措施: Activity Monitoring-Wrist worn wearable (Device)

Activity Monitoring-Waist-worn wearable

Active Comparator

Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months.

干预措施: Activity Monitoring-Waist-worn wearable (Device)

结局指标

主要结局

Change in hemoglobin A1c

时间窗: 6 months

Change in hemoglobin A1c from baseline to 6 months

次要结局

  • Change in low-density lipoprotein (LDL) levels(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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